A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

NCT06997497 | Recruiting Phase 3 DMC FDA Drug

• 6 other identifiers: 1084-012MK-1084-012KANDLELIT-0122024-517232-22-00U1111-1311-8311jRCT2031250265
• Study Type: interventional
• Target: 477
• Locations: 28 countries
• Sites: 217

Brief Summary

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C. Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies. The goals of this study are to learn:

• About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments
• If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

Conditions

Rectal Adenocarcinoma; Colon Adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• Number of Participants Experiencing Dose-Limiting Toxicity (DLT)

  A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration.

  Up to approximately 28 days

• Part 1: Number of Participants Who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to approximately 44 months

• Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to approximately 44 months

• Progression Free Survival (PFS)

  PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

  Up to approximately 44 months

Secondary Outcomes (15)

• Objective Response Rate (ORR)

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 5 years

• Duration of Response (DOR)

  Up to approximately 4 years

• Part 2: Number of Participants with an Adverse Event (AE)

  Up to approximately 5 years

• Part 2: Number of Participants who Discontinue Study Treatment Due to an AE

  Up to approximately 5 years

Study Arms (2)

Calderasib + Cetuximab + mFOLFOX6

EXPERIMENTAL

Participants will receive calderasib orally, cetuximab per label every 2 weeks (Q2W), and mFOLFOX6 chemotherapy: oxaliplatin per label every 2 weeks (Q2W), leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Treatment will continue until criteria for discontinuation is met.

Drug: Calderasib; Drug: Oxaliplatin; Drug: Leucovorin/levofolinate calcium; Drug: 5-Fluorouracil; Biological: Cetuximab

mFOLFOX6

ACTIVE COMPARATOR

Participants will receive mFOLFOX6 chemotherapy: oxaliplatin per label Q2W, leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Participants may also receive bevacizumab or bevacizumab biosimilar Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met.

Drug: Oxaliplatin; Drug: Leucovorin/levofolinate calcium; Drug: 5-Fluorouracil; Drug: Bevacizumab; Drug: Bevacizumab biosimilar

Interventions

Bevacizumab DRUG

Per label

Also known as: Avastin

mFOLFOX6

Bevacizumab biosimilar DRUG

Per label

Also known as: MVASI

mFOLFOX6

5-Fluorouracil DRUG

Per label

Calderasib + Cetuximab + mFOLFOX6; mFOLFOX6

Calderasib DRUG

Oral tablet

Also known as: MK-1084

Calderasib + Cetuximab + mFOLFOX6

Cetuximab BIOLOGICAL

Per label

Also known as: Erbitux

Calderasib + Cetuximab + mFOLFOX6

Oxaliplatin DRUG

Per label

Calderasib + Cetuximab + mFOLFOX6; mFOLFOX6

Leucovorin/levofolinate calcium DRUG

Per label

Calderasib + Cetuximab + mFOLFOX6; mFOLFOX6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer \[AJCC\] eighth edition) colorectal adenocarcinoma
• Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period
• Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

You may not qualify if:

• Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy
• Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
• Has active infection requiring systemic therapy
• Has not adequately recovered from major surgery or have ongoing surgical complications
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (217)

Los Angeles Hematology Oncology Medical Group ( Site 0084)

Los Angeles, California, 90017, United States

RECRUITING

UCLA Hematology/Oncology - Santa Monica ( Site 0088)

Santa Monica, California, 90404, United States

RECRUITING

University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087)

Fort Collins, Colorado, 80528, United States

RECRUITING

Rocky Mountain Cancer Centers (RMCC) ( Site 8000)

Lone Tree, Colorado, 80124, United States

RECRUITING

Florida Cancer Specialists - South ( Site 7002)

Fort Myers, Florida, 33901, United States

RECRUITING

Orlando Health Cancer Institute ( Site 0065)

Orlando, Florida, 32806, United States

RECRUITING

Florida Cancer Specialists - North ( Site 7001)

St. Petersburg, Florida, 33705, United States

RECRUITING

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, Florida, 33401, United States

RECRUITING

Saint Alphonsus Regional Medical Center ( Site 0085)

Boise, Idaho, 83706, United States

RECRUITING

Accellacare of Duly ( Site 2015)

Lisle, Illinois, 60532, United States

RECRUITING

University of Iowa ( Site 0074)

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky ( Site 0055)

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)

Louisville, Kentucky, 40217, United States

RECRUITING

Greater Baltimore Medical Center ( Site 0068)

Baltimore, Maryland, 21204, United States

RECRUITING

Hattiesburg Clinic ( Site 0064)

Hattiesburg, Mississippi, 39401, United States

RECRUITING

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)

Billings, Montana, 59102, United States

RECRUITING

University Of Nebraska Medical Center ( Site 0078)

Omaha, Nebraska, 68198, United States

RECRUITING

Renown Regional Medical Center ( Site 0056)

Reno, Nevada, 89502, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)

Hackensack, New Jersey, 07601, United States

RECRUITING

Atlantic Health System ( Site 0093)

Summit, New Jersey, 07901, United States

RECRUITING

San Juan Oncology Associates, P.C ( Site 2011)

Farmington, New Mexico, 87401, United States

RECRUITING

Ellis Hospital ( Site 0098)

Schenectady, New York, 12308, United States

RECRUITING

Miami Valley Hospital South ( Site 0075)

Centerville, Ohio, 45459, United States

RECRUITING

Texas Oncology - DFW ( Site 8002)

Dallas, Texas, 75246, United States

RECRUITING

UT Southwestern Medical Center ( Site 0059)

Dallas, Texas, 75390, United States

RECRUITING

Texas Oncology - Northeast Texas ( Site 8001)

Denison, Texas, 75020, United States

RECRUITING

Texas Oncology - San Antonio ( Site 8004)

San Antonio, Texas, 78240, United States

RECRUITING

Community Cancer Trials of Utah ( Site 0086)

Ogden, Utah, 84405, United States

RECRUITING

University of Virginia ( Site 0080)

Charlottesville, Virginia, 22908, United States

RECRUITING

Virginia Cancer Specialists, PC ( Site 0069)

Fairfax, Virginia, 22031, United States

RECRUITING

Fred Hutchinson Cancer Center ( Site 0076)

Seattle, Washington, 98109, United States

RECRUITING

West Virginia University ( Site 2017)

Morgantown, West Virginia, 26506, United States

RECRUITING

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0110)

Berazategui, Buenos Aires, B1884BBF, Argentina

RECRUITING

Hospital Italiano de Buenos Aires ( Site 0102)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

RECRUITING

Instituto Alexander Fleming ( Site 0101)

Mar del Plata, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Fundacion Estudios Clinicos ( Site 0105)

Rosario, Santa Fe Province, S2000CEJ, Argentina

RECRUITING

Sanatorio Parque ( Site 0103)

Rosario, Santa Fe Province, S2000CUB, Argentina

RECRUITING

Hospital Privado Universitario de Córdoba ( Site 0108)

Córdoba, X5016KEH, Argentina

RECRUITING

Wollongong Hospital ( Site 0453)

Wollongong, New South Wales, 2500, Australia

RECRUITING

Sunshine Coast University Hospital ( Site 0451)

Birtinya, Queensland, 4575, Australia

RECRUITING

Monash Health ( Site 0454)

Clayton, Victoria, 3168, Australia

RECRUITING

Western Health-Sunshine & Footscray Hospitals ( Site 0450)

St Albans, Victoria, 3021, Australia

RECRUITING

Hospital de Câncer de Recife ( Site 0158)

Recife, Pernambuco, 50040-000, Brazil

RECRUITING

Hospital de Caridade de Ijuí ( Site 0150)

Ijuí, Rio Grande do Sul, 98700-000, Brazil

RECRUITING

Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

RECRUITING

Hospital Nossa Senhora da Conceição ( Site 0156)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

RECRUITING

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)

Florianópolis, Santa Catarina, 88020-210, Brazil

RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

COE Ensino e Pesquisa ( Site 0151)

São José dos Campos, São Paulo, 12242-660, Brazil

RECRUITING

Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)

São Paulo, 01209-000, Brazil

RECRUITING

IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)

São Paulo, 04014-002, Brazil

RECRUITING

Cancercare Manitoba ( Site 0009)

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

Moncton Hospital - Horizon Health Network ( Site 0011)

Moncton, New Brunswick, E1C 6Z8, Canada

RECRUITING

Princess Margaret Cancer Centre ( Site 0001)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CIUSSS- saguenay-Lac-Saint-Jean ( Site 0007)

Chicoutimi, Quebec, G7H 5H6, Canada

RECRUITING

Jewish General Hospital ( Site 0006)

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

CIDO SpA ( Site 0212)

Temuco, Araucania, 4810148, Chile

RECRUITING

Clínica Puerto Montt ( Site 0206)

Port Montt, Los Lagos Region, 5500243, Chile

RECRUITING

Oncocentro Valdivia ( Site 0204)

Valdivia, Los Ríos Region, 5112129, Chile

RECRUITING

Fundacion Arturo Lopez Perez ( Site 0201)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Centro de Oncología de Precisión ( Site 0207)

Santiago, Region M. de Santiago, 7560908, Chile

RECRUITING

Clínica UC San Carlos de Apoquindo ( Site 0211)

Santiago, Region M. de Santiago, 7620002, Chile

RECRUITING

CECIM ( Site 0210)

Santiago, Region M. de Santiago, 8331143, Chile

RECRUITING

Bradfordhill ( Site 0200)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Clínica RedSalud Vitacura ( Site 0202)

Vitacura, Region M. de Santiago, 7650018, Chile

RECRUITING

ONCOCENTRO APYS ( Site 0203)

Viña del Mar, Valparaiso, 2520598, Chile

RECRUITING

Anhui Provincial Cancer Hospital ( Site 0803)

Hefei, Anhui, 230031, China

RECRUITING

The Second Affiliated Hospital of Anhui Medical University ( Site 0813)

Hefei, Anhui, 230601, China

RECRUITING

Peking Union Medical College Hospital ( Site 0824)

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking University First Hospital(Daxing Area) ( Site 0838)

Beijing, Beijing Municipality, 102627, China

RECRUITING

Chongqing University Cancer Hospital ( Site 0808)

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Chongqing University Three Gorges Hospital ( Site 0837)

Wanzhou, Chongqing Municipality, 404199, China

RECRUITING

Fujian Cancer Hospital ( Site 0807)

Fuzhou, Fujian, 350014, China

RECRUITING

The First Affiliated Hospital of Xiamen University ( Site 0806)

Xiamen, Fujian, 361003, China

RECRUITING

Zhongshan Hospital Affiliated to Xiamen University ( Site 1902)

Xiamen, Fujian, 361004, China

RECRUITING

Sun Yat-Sen University Cancer Center ( Site 0800)

Guangzhou, Guangdong, 510060, China

RECRUITING

Southern Medical University Nanfang Hospital ( Site 0812)

Guangzhou, Guangdong, 510515, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)

Guangzhou, Guangdong, 510655, China

RECRUITING

The University of Hong Kong - Shenzhen Hospital ( Site 1903)

Shenzhen, Guangdong, 518053, China

RECRUITING

Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)

Nanning, Guangxi, 530200, China

RECRUITING

Harbin Medical University Cancer Hospital ( Site 0847)

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital ( Site 0822)

Zhengzhou, Henan, 450008, China

RECRUITING

Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)

Wuhan, Hubei, 430030, China

RECRUITING

Hubei Cancer Hospital ( Site 0814)

Wuhan, Hubei, 430079, China

RECRUITING

Hunan Cancer Hospital ( Site 0815)

Changsha, Hunan, 410013, China

RECRUITING

The Third Xiangya Hospital of Central South University ( Site 0834)

Changsha, Hunan, 410013, China

RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)

Nanjing, Jiangsu, 210000, China

RECRUITING

The First Affiliated Hospital of Nanchang University ( Site 0826)

Nanchang, Jiangxi, 330200, China

RECRUITING

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0802)

Xi'an, Shaanxi, 710061, China

RECRUITING

Jinan Central Hospital ( Site 0817)

Jinan, Shandong, 250013, China

RECRUITING

Zhongshan Hospital of Fudan University ( Site 0832)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center ( Site 0816)

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 1906)

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

First Affiliated Hospital of Shanxi Medical University ( Site 0843)

Taiyuan, Shanxi, 030001, China

RECRUITING

West China Hospital, Sichuan University ( Site 0805)

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan Cancer hospital. ( Site 0831)

Chengdu, Sichuan, 610213, China

RECRUITING

First Affiliated Hospital of Kunming Medical University ( Site 0845)

Kunming, Yunnan, 650032, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801)

Hangzhou, Zhejiang, 310017, China

RECRUITING

Zhejiang Cancer Hospital ( Site 0821)

Hangzhou, Zhejiang, 310022, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)

Wenzhou, Zhejiang, 325000, China

RECRUITING

Hospital Universitario San Ignacio ( Site 0254)

Bogota, Cundinamarca, 110231, Colombia

RECRUITING

IMAT S.A.S ( Site 0252)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Oncologos Del Occidente ( Site 0255)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Tampere University Hospital ( Site 1001)

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)

Helsinki, Uusimaa, 00290, Finland

RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)

Nice, Alpes-Maritimes, 06202, France

RECRUITING

Centre François Baclesse ( Site 1061)

Caen, Calvados, 14000, France

RECRUITING

CHU Rangueil ( Site 1063)

Toulouse, Haute-Garonne, 31059, France

RECRUITING

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)

Limoges, Limousin, 87042, France

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)

Vandœuvre-lès-Nancy, Lorraine, 54511, France

RECRUITING

Institut Jean Godinot ( Site 1054)

Reims, Marne, 51100, France

RECRUITING

Institut de Cancérologie de l'Ouest ( Site 1062)

Angers, Pays de la Loire Region, 49055, France

RECRUITING

CHU Charles Nicolle ( Site 1066)

Rouen, Seine-Maritime, 76031, France

RECRUITING

Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)

Avignon, Vaucluse, 84918, France

RECRUITING

Hôpital Saint Antoine ( Site 1051)

Paris, 75571, France

RECRUITING

Hôpital Européen Georges Pompidou ( Site 1050)

Paris, Île-de-France Region, 75015, France

RECRUITING

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1104)

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

Katholisches Marienkrankenhaus gGmbH ( Site 1103)

Hamburg, 22087, Germany

RECRUITING

Asklepios Klinik Altona ( Site 1100)

Hamburg, 22763, Germany

RECRUITING

Prince of Wales Hospital. ( Site 0500)

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital ( Site 0501)

Hong Kong, Hong Kong

RECRUITING

Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204)

Pécs, Baranya, 7624, Hungary

RECRUITING

Rambam Health Care Campus ( Site 1253)

Haifa, 3109601, Israel

RECRUITING

Hadassah Medical Center ( Site 1252)

Jerusalem, 9112001, Israel

RECRUITING

Rabin Medical Center ( Site 1251)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 1254)

Ramat Gan, 5265601, Israel

RECRUITING

Sourasky Medical Center ( Site 1255)

Tel Aviv, 6423906, Israel

RECRUITING

AOU Cagliari ( Site 1306)

Monserrato, Cagliari, 09042, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda ( Site 1300)

Milan, Lombardy, 20162, Italy

RECRUITING

Ospedale San Raffaele. ( Site 1305)

Milan, 20132, Italy

RECRUITING

Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302)

Naples, 80131, Italy

RECRUITING

Istituto Oncologico Veneto IRCCS ( Site 1307)

Padova, 35128, Italy

RECRUITING

Azienda USL della Romagna ( Site 1303)

Ravenna, 48100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)

Verona, 37134, Italy

RECRUITING

National Cancer Center Hospital East ( Site 0851)

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Teine Keijinkai Hospital ( Site 0864)

Sapporo, Hokkaido, 006-8555, Japan

RECRUITING

Kagawa University Hospital ( Site 0861)

Kita-gun, Kagawa-ken, 761-0793, Japan

RECRUITING

Kanagawa Cancer Center ( Site 0865)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Tohoku University Hospital ( Site 0853)

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Kindai University Hospital ( Site 0854)

Sakai, Osaka, 590-0197, Japan

RECRUITING

Saitama Medical University International Medical Center ( Site 0860)

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Saitama Prefectural Cancer Center ( Site 0857)

Kitaadachi-gun, Saitama, 362-0806, Japan

RECRUITING

Shizuoka Cancer Center ( Site 0856)

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

Nippon Medical School Hospital ( Site 0859)

Bunkyo, Tokyo, 113-8603, Japan

RECRUITING

National Cancer Center Hospital ( Site 0850)

Chūō, Tokyo, 104-0045, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 0863)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Chiba Cancer Center ( Site 0858)

Chiba, 260-8717, Japan

RECRUITING

Kyushu University Hospital ( Site 0862)

Fukuoka, 812-8582, Japan

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0852)

Osaka, 541-8567, Japan

RECRUITING

Hospital Pulau Pinang ( Site 0550)

George Town, Pulau Pinang, 10990, Malaysia

RECRUITING

National Cancer Institute ( Site 0552)

Putrajaya, Putrajaya, 62250, Malaysia

RECRUITING

Sarawak General Hospital ( Site 0551)

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Centro de Inmuno Oncología de Occidente SA de CV ( Site 0403)

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Higiea Oncologia ( Site 0404)

Mexico City, Mexico City, 11810, Mexico

RECRUITING

Oncare Oncology (Servicios de Oncologia Médica Integral S.A. de C.V. - unidad San Pedro) ( Site 0407)

San Pedro Garza García, Nuevo León, 66220, Mexico

RECRUITING

Centro de Investigación Oncológica Galerías SC ( Site 0408)

Aguascalientes, 20124, Mexico

RECRUITING

Centro de Investigacion Clinica de Oaxaca ( Site 0402)

Oaxaca City, 68020, Mexico

RECRUITING

Radboudumc ( Site 1354)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)

Breda, North Brabant, 4818 CK, Netherlands

RECRUITING

Amsterdam UMC, locatie VUmc ( Site 1351)

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Erasmus Medisch Centrum ( Site 1353)

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)

Poznan, Greater Poland Voivodeship, 61-866, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1451)

Warsaw, Masovian Voivodeship, 02-034, Poland

RECRUITING

Mrukmed ( Site 1450)

Rzeszów, Podkarpackie Voivodeship, 35-021, Poland

RECRUITING

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1452)

Gliwice, Silesian Voivodeship, 44-101, Poland

RECRUITING

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 1456)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

RECRUITING

Institutul Oncologic Cluj ( Site 1502)

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)

Cluj-Napoca, Cluj, 407280, Romania

RECRUITING

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)

Craiova, Dolj, 200746, Romania

RECRUITING

Fundeni Clinical Institute-Medical Oncology ( Site 1504)

Bucharest, 022328, Romania

RECRUITING

Institutul Regional de Oncologie ( Site 1505)

Iași, 700483, Romania

RECRUITING

National Cancer Centre Singapore ( Site 0650)

Singapore, Central Singapore, 168583, Singapore

RECRUITING

National Cancer Center ( Site 0702)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

Seoul National University Bundang Hospital ( Site 0705)

Seongnam-si, Kyonggi-do, 13620, South Korea

RECRUITING

The Catholic University of Korea St. Vincent s Hospital ( Site 0703)

Suwon, Kyonggi-do, 16247, South Korea

RECRUITING

Samsung Medical Center ( Site 0708)

Gangnam, Seoul, 06351, South Korea

RECRUITING

Asan Medical Center ( Site 0707)

Songpa-gu, Seoul, 05505, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital ( Site 0701)

Buk-Gu, Taegu-Kwangyokshi, 41404, South Korea

RECRUITING

Seoul National University Hospital ( Site 0706)

Seoul, 03080, South Korea

RECRUITING

Korea University Guro Hospital ( Site 0704)

Seoul, 08308, South Korea

RECRUITING

Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla ( Site 1551)

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Insular de Gran Canaria ( Site 1558)

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

Hospital Universitario Central de Asturias ( Site 1550)

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 1553)

Barcelona, 08035, Spain

RECRUITING

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)

Madrid, 28007, Spain

RECRUITING

Hospital Clinico San Carlos ( Site 1555)

Madrid, 28040, Spain

RECRUITING

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)

Seville, 41013, Spain

RECRUITING

Instituto Valenciano de Oncologia - IVO ( Site 1557)

Valencia, 46009, Spain

RECRUITING

National Cheng Kung University Hospital ( Site 0754)

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 0751)

Taipei, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 0752)

Taipei, 112, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)

Taoyuan, 333, Taiwan

RECRUITING

Hacettepe Universite Hastaneleri ( Site 1650)

Sıhhiye, Ankara, 06230, Turkey (Türkiye)

RECRUITING

Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1652)

Adana, 01250, Turkey (Türkiye)

RECRUITING

Gazi Universitesi ( Site 1651)

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Dicle Üniversitesi ( Site 1654)

Diyarbakır, 21200, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa ( Site 1656)

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Ege Universitesi Hastanesi ( Site 1653)

Izmir, 35080, Turkey (Türkiye)

RECRUITING

MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

RECRUITING

RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)

Chernivtsi, Chernivetska Oblast, 58013, Ukraine

RECRUITING

MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)

Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

RECRUITING

MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)

Lviv, Lviv Oblast, 79059, Ukraine

RECRUITING

MNE "Central City Hospital" ( Site 1711)

Rivne, Rivne Oblast, 33017, Ukraine

RECRUITING

ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)

Lutsk, Volyn Oblast, 43018, Ukraine

RECRUITING

Uzhgorod Central City Clinical Hospital ( Site 1700)

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

RECRUITING

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)

Kyiv, 03057, Ukraine

RECRUITING

SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)

Kyiv, 03126, Ukraine

RECRUITING

LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)

Kyiv, 03151, Ukraine

RECRUITING

Heartlands Hospital ( Site 1759)

Birmingham, England, B9 5ss, United Kingdom

RECRUITING

University College London Hospitals ( Site 1750)

London, London, City of, NW1 2PG, United Kingdom

RECRUITING

Churchill Hospital ( Site 1756)

Oxford, Oxfordshire, ox3 7le, United Kingdom

RECRUITING

University Hospital Coventry & Warwickshire ( Site 1761)

Coventry, Warwickshire, CV2 2DX, United Kingdom

RECRUITING

Velindre Cancer Centre Hospital ( Site 1753)

Cardiff, CF14 2TL, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 1755)

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Cetuximab; Bevacizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): March 28, 2029
• Study Completion (Estimated): October 27, 2030
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (5); ME (5); NL (4); DE (3); HU (1); FI (2); CL (10); AU (4); CO (3); US (32); RO (5); IL (5); AR (6); KR (8); TU (6); UA (11); MY (3); TW (4); ES (9); BR (10); GB (6); CN (34); JP (15); PL (5); HK (2); SG (1); IT (7); FR (11)